米国の原薬CDMO市場規模、シェア、動向分析レポート：製品別、合成別、薬剤別、ワークフロー別、用途別、セグメント別予測、2025～2030年

市場規模と動向

米国の原薬CDMO市場は、2024年に252億8,000万米ドルと評価され、2025～2030年にかけてCAGR 5.1%で成長し、2030年には338億6,000万米ドルに達すると予測されています。

この成長の背景には、革新的な薬剤や治療法の開発をサポートする先進的薬剤製造サービスに対する需要の高まりがあります。また、生物製剤や高力価原薬への投資の増加が市場拡大の原動力となっています。慢性疾患の蔓延と、効率的でスケーラブルな生産ソリューションへのニーズの高まりも、市場の勢いに寄与しています。

この市場成長を支える主要促進要因には、歩留まりを向上させ、無駄を省き、製品の品質を高めるプロセス化学と製造自動化の技術進歩が含まれます。専門CDMOへのアウトソーシングを奨励する規制上の支援は不可欠であり、これらの組織は厳格なFDAと国際基準の遵守を保証するのに役立つからです。個別化医療や新規治療への注目が高まるにつれ、少量生産で複雑な原薬製造の需要が高まっており、CDMOはその柔軟性と専門性により得意とするセグメントです。製薬企業とCDMOの協力関係の高まりもイノベーションを促進し、市場投入までの時間を短縮することで、企業は進化する患者のより良いニーズに応えることができます。

同市場は、特に高度に専門化された原薬製造を必要とする生物製剤、遺伝子治療、細胞治療の開発において、大きなビジネス機会をもたらしています。連続製造とフローケミストリーの動向は、CDMOがコストと環境への影響を削減しながら効率とスケーラビリティを改善する道を記載しています。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 米国の原薬CDMO市場の変数、動向、範囲

• 市場系統の展望
• 市場力学
  • 市場促進要因分析
  • 市場抑制要因分析
  • 産業の課題
• 産業分析ツール
  • ポーター分析
  • PESTEL分析

第4章 米国の原薬CDMO市場：製品別、推定・動向分析

• 米国の原薬CDMO市場、製品別：主要ポイント
• 製品変動分析と市場シェア、2024年と2030年
• 製品別、2018～2030年
  • 伝統的有効薬剤成分
  • 非常に強力な有効薬剤成分
  • 抗体薬剤複合体（ADC）
  • その他

第5章 米国の原薬CDMO市場：合成別、推定・動向分析

• 米国の原薬CDMO市場、合成別：主要ポイント
• 合成変動分析と市場シェア、2024年と2030年
• 合成別、2018～2030年
  • 合成
  • バイオテクノロジー

第6章 米国の原薬CDMO市場：薬剤別、推定・動向分析

• 米国の原薬CDMO市場、薬剤別：主要ポイント
• 薬剤変動分析と市場シェア、2024年と2030年
• 薬剤別、2018～2030年
  • 革新的
  • ジェネリック

第7章 米国の原薬CDMO市場：ワークフロー別、推定・動向分析

• 米国原薬CDMO市場、ワークフロー別：主要ポイント
• ワークフロー変動分析と市場シェア、2024年と2030年
• ワークフロー別、2018～2030年
  • 臨床
  • 商用

第8章 米国の原薬CDMO市場：用途別、推定・動向分析

• 米国の原薬CDMO市場、用途別：主要ポイント
• 用途変動分析と市場シェア、2024年と2030年
• 用途別、2018～2030年
  • 腫瘍学
  • ホルモン
  • 緑内障
  • 心血管疾患
  • 糖尿病
  • その他

第9章 競合情勢

• 企業分類
• 企業の市場ポジショニング
• 企業ヒートマップ分析
• 企業プロファイル/上場企業
  • Thermo Fisher Scientific Inc.
  • Novo Group（Catalent, Inc.）
  • Cambrex Corporation
  • Piramal Pharma Limited
  • Corden Pharma
  • Siegfried Holding AG
  • Seqens North America
  • SK pharmteco Inc.
  • Noramco.
  • BSP Pharmaceuticals

List of Tables

• Table 1 List of abbreviations
• Table 2 U.S active pharmaceutical ingredients CDMO market: key market driver analysis
• Table 3 U.S active pharmaceutical ingredients CDMO market: Key market restraint analysis
• Table 4 U.S active pharmaceutical ingredients CDMO market estimates and forecast, by product (USD Million)
• Table 5 U.S active pharmaceutical ingredients CDMO market estimates and forecast, by synthesis (USD Million)
• Table 6 U.S active pharmaceutical ingredients CDMO market estimates and forecast, by drug (USD Million)
• Table 7 U.S active pharmaceutical ingredients CDMO market estimates and forecast, by workflow (USD Million)
• Table 8 U.S active pharmaceutical ingredients CDMO market estimates and forecast, by application (USD Million)
• Table 9 Recent developments and impact analysis by key market participants
• Table 10 Company heat map analysis, 2024
• Table 11 Companies implementing key strategies

List of Figures

• Fig. 1 U.S active pharmaceutical ingredients CDMO market segmentation
• Fig. 2 Market research process
• Fig. 3 Information procurement
• Fig. 4 Primary research pattern
• Fig. 5 Market research approaches
• Fig. 6 Value chain-based sizing and forecasting
• Fig. 7 Parent market analysis
• Fig. 8 Market formulation and validation
• Fig. 9 U.S active pharmaceutical ingredients CDMO market snapshot
• Fig. 10 U.S active pharmaceutical ingredients CDMO market segment snapshot
• Fig. 11 U.S active pharmaceutical ingredients CDMO market competitive landscape snapshot
• Fig. 12 Market research process
• Fig. 13 Market driver relevance analysis (Current and future impact)
• Fig. 14 Market restraint relevance analysis (Current and future impact)
• Fig. 15 U.S active pharmaceutical ingredients CDMO market: Product outlook key takeaways (USD Million)
• Fig. 16 U.S active pharmaceutical ingredients CDMO market: Product movement analysis 2024 & 2030 (USD Million)
• Fig. 17 Traditional Active Pharmaceutical Ingredient market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 18 Highly Potent Active Pharmaceutical Ingredient market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 19 Antibody Drug Conjugate (ADC)s market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 20 Others market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 21 U.S active pharmaceutical ingredients CDMO market: Synthesis outlook key takeaways (USD Million)
• Fig. 22 U.S active pharmaceutical ingredients CDMO market: Synthesis movement analysis 2024 & 2030 (USD Million)
• Fig. 23 Synthetic market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 24 Biotech market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 25 U.S active pharmaceutical ingredients CDMO market: Drug outlook key takeaways (USD Million)
• Fig. 26 U.S active pharmaceutical ingredients CDMO market: Drug movement analysis 2024 & 2030 (USD Million)
• Fig. 27 Innovative market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 28 Generics market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 29 Distributed recipient drugs market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 30 U.S active pharmaceutical ingredients CDMO market: Workflow outlook key takeaways (USD Million)
• Fig. 31 U.S active pharmaceutical ingredients CDMO market: Workflow movement analysis 2024 & 2030 (USD Million)
• Fig. 32 Clinical market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 33 Commercial market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 34 U.S active pharmaceutical ingredients CDMO market: Application outlook key takeaways (USD Million)
• Fig. 35 U.S active pharmaceutical ingredients CDMO market: Application movement analysis 2024 & 2030 (USD Million)
• Fig. 36 Oncology market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 37 Hormonal market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 38 Glaucoma market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 39 Cardiovascular disease market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 40 Diabetes market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 41 Others market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 42 Strategy framework
• Fig. 43 Company categorization

Market Size & Trends:

The U.S. active pharmaceutical ingredients CDMO market was valued at USD 25.28 billion in 2024 and is projected to reach USD 33.86 billion by 2030, growing at a CAGR of 5.1% from 2025 to 2030. This growth is driven by rising demand for advanced pharmaceutical manufacturing services to support the development of innovative drugs and therapies. In addition, increasing investments in biologics and high-potency APIs drive market expansion. The growing prevalence of chronic diseases and the need for efficient, scalable production solutions also contribute to the market's momentum.

Key drivers supporting this market growth include technological advancements in process chemistry and manufacturing automation, which improve yield, reduce waste, and enhance product quality. Regulatory support encouraging outsourcing to specialized CDMOs is vital, as these organizations help ensure compliance with stringent FDA and international standards. The increasing focus on personalized medicine and novel therapies drives demand for small-batch, complex API manufacturing, areas where CDMOs excel due to their flexibility and expertise. Growing collaborations between pharmaceutical firms and CDMOs also foster innovation and accelerate time-to-market, enabling companies to meet better evolving patient better needs.

The market presents significant opportunities, especially in developing biologics, gene therapies, and cell therapies requiring highly specialized API manufacturing. The trend toward continuous manufacturing and flow chemistry offers avenues for CDMOs to improve efficiency and scalability while reducing costs and environmental impact.

U.S. Active Pharmaceutical Ingredients CDMO Market Report Segmentation

This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. active pharmaceutical ingredients CDMO market report based on product, synthesis, drug, workflow, and application.

• Product Outlook (Revenue, USD Million, 2018 - 2030)
• Traditional Active Pharmaceutical Ingredient
• Highly Potent Active Pharmaceutical Ingredient
• Antibody Drug Conjugate (ADC)
• Other
• Synthesis Outlook (Revenue, USD Million, 2018 - 2030)
• Synthetic
• Biotech
• Drug Outlook (Revenue, USD Million, 2018 - 2030)
• Innovative
• Generic
• Workflow Outlook (Revenue, USD Million, 2018 - 2030)
• Clinical
• Commercial
• Application Outlook (Revenue, USD Million, 2018 - 2030)
• Oncology
• Hormonal
• Glaucoma
• Cardiovascular disease
• Diabetes
• Others

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definition
• 1.3. Information Procurement
  • 1.3.1. Purchased Database
  • 1.3.2. GVR's Internal Database
  • 1.3.3. Secondary Sources and Third-Party Perspectives
  • 1.3.4. Primary Research
• 1.4. Information Analysis
  • 1.4.1. Data Analysis Models
• 1.5. Market Formulation and Data Visualization
• 1.6. Data Validation and Publishing

Chapter 2. Executive Summary

• 2.1. Market Snapshot
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. U.S. Active Pharmaceutical Ingredients CDMO Market Variables, Trends and Scope

• 3.1. Market Lineage Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
  • 3.2.3. Industry Challenge
• 3.3. Industry Analysis Tools
  • 3.3.1. PORTER's Analysis
    • 3.3.1.1. Bargaining power of the suppliers
    • 3.3.1.2. Bargaining power of the buyers
    • 3.3.1.3. Threats of substitution
    • 3.3.1.4. Threats from new entrants
    • 3.3.1.5. Competitive rivalry
  • 3.3.2. PESTEL Analysis
    • 3.3.2.1. Political landscape
    • 3.3.2.2. Economic and social landscape
    • 3.3.2.3. Technological landscape

Chapter 4. U.S. Active Pharmaceutical Ingredients CDMO Market: Product Estimates and Trend Analysis

• 4.1. U.S. Active Pharmaceutical Ingredients CDMO Market, By Product: Key Takeaways
• 4.2. Product Movement Analysis and Market Share, 2024 and 2030
• 4.3. Market Estimates and Forecasts, By Product, 2018 - 2030 (USD Million)
  • 4.3.1. Traditional Active Pharmaceutical Ingredient
    • 4.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.3.2. Highly Potent Active Pharmaceutical Ingredient
    • 4.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.3.3. Antibody Drug Conjugate (ADC)
    • 4.3.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.3.4. Other
    • 4.3.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. U.S. Active Pharmaceutical Ingredients CDMO Market: Synthesis Estimates and Trend Analysis

• 5.1. U.S. Active Pharmaceutical Ingredients CDMO Market, By Synthesis: Key Takeaways
• 5.2. Synthesis Movement Analysis and Market Share, 2024 and 2030
• 5.3. Market Estimates and Forecasts, By Synthesis, 2018 - 2030 (USD Million)
  • 5.3.1. Synthetic
    • 5.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.3.2. Biotech
    • 5.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. U.S. Active Pharmaceutical Ingredients CDMO Market: Drug Estimates and Trend Analysis

• 6.1. U.S. Active Pharmaceutical Ingredients CDMO Market, By Drug: Key Takeaways
• 6.2. Drug Movement Analysis and Market Share, 2024 and 2030
• 6.3. Market Estimates and Forecasts, By Drug, 2018 - 2030 (USD Million)
  • 6.3.1. Innovative
    • 6.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.3.2. Generic
    • 6.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 7. U.S. Active Pharmaceutical Ingredients CDMO Market: Workflow Estimates and Trend Analysis

• 7.1. U.S. Active Pharmaceutical Ingredients CDMO Market, By Workflow: Key Takeaways
• 7.2. Workflow Movement Analysis and Market Share, 2024 and 2030
• 7.3. Market Estimates and Forecasts, By Workflow, 2018 - 2030 (USD Million)
  • 7.3.1. Clinical
    • 7.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 7.3.2. Commercial
    • 7.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 8. U.S. Active Pharmaceutical Ingredients CDMO Market: Application Estimates and Trend Analysis

• 8.1. U.S. Active Pharmaceutical Ingredients CDMO Market, By Application: Key Takeaways
• 8.2. Application Movement Analysis and Market Share, 2024 and 2030
• 8.3. Market Estimates and Forecasts, By Application, 2018 - 2030 (USD Million)
  • 8.3.1. Oncology
    • 8.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.2. Hormonal
    • 8.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.3. Glaucoma
    • 8.3.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.4. Cardiovascular disease
    • 8.3.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.5. Diabetes
    • 8.3.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.6. Others
    • 8.3.6.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Company Categorization
• 9.2. Company Market Positioning
• 9.3. Company Heat Map Analysis
• 9.4. Company Profiles/Listing
  • 9.4.1. Thermo Fisher Scientific Inc.
    • 9.4.1.1. Company Overview
    • 9.4.1.2. Financial Performance
    • 9.4.1.3. Product Portfolio
    • 9.4.1.4. Recent Developments/ Strategic Initiatives
  • 9.4.2. Novo Group (Catalent, Inc.)
    • 9.4.2.1. Company Overview
    • 9.4.2.2. Financial Performance
    • 9.4.2.3. Product Portfolio
    • 9.4.2.4. Recent Developments/ Strategic Initiatives
  • 9.4.3. Cambrex Corporation
    • 9.4.3.1. Company Overview
    • 9.4.3.2. Financial Performance
    • 9.4.3.3. Product Portfolio
    • 9.4.3.4. Recent Developments/ Strategic Initiatives
  • 9.4.4. Piramal Pharma Limited
    • 9.4.4.1. Company Overview
    • 9.4.4.2. Financial Performance
    • 9.4.4.3. Product Portfolio
    • 9.4.4.4. Recent Developments/ Strategic Initiatives
  • 9.4.5. Corden Pharma
    • 9.4.5.1. Company Overview
    • 9.4.5.2. Financial Performance
    • 9.4.5.3. Product Portfolio
    • 9.4.5.4. Recent Developments/ Strategic Initiatives
  • 9.4.6. Siegfried Holding AG
    • 9.4.6.1. Company Overview
    • 9.4.6.2. Financial Performance
    • 9.4.6.3. Product Portfolio
    • 9.4.6.4. Recent Developments/ Strategic Initiatives
  • 9.4.7. Seqens North America
    • 9.4.7.1. Company Overview
    • 9.4.7.2. Financial Performance
    • 9.4.7.3. Product Portfolio
    • 9.4.7.4. Recent Developments/ Strategic Initiatives
  • 9.4.8. SK pharmteco Inc.
    • 9.4.8.1. Company Overview
    • 9.4.8.2. Financial Performance
    • 9.4.8.3. Product Portfolio
    • 9.4.8.4. Recent Developments/ Strategic Initiatives
  • 9.4.9. Noramco.
    • 9.4.9.1. Company Overview
    • 9.4.9.2. Financial Performance
    • 9.4.9.3. Product Portfolio
    • 9.4.9.4. Recent Developments/ Strategic Initiatives
  • 9.4.10. BSP Pharmaceuticals
    • 9.4.10.1. Company Overview
    • 9.4.10.2. Financial Performance
    • 9.4.10.3. Product Portfolio
    • 9.4.10.4. Recent Developments/ Strategic Initiatives